MASADA Modular Spinal Fixation System— 510(k) K231694
Substantially EquivalentAstura Medical
FDA 510(k) clearance K231694 for MASADA Modular Spinal Fixation System, Substantially Equivalent on 2023-11-16. Applicant: Astura Medical. Device class: 2.
Clearance details
- Applicant
- Astura Medical
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
Recent devices under product code NKB
view all- K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253943 — Tiger 2 System
- K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
More clearances from Astura Medical
view all- K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K252346 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K243259 — MASADA Modular Spinal Fixation System
- K240160 — EGPS Navigated Instruments
- K233359 — DOMINION Expandable Corpectomy System
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.